Stroke, AcutePhase 1/2NCT00535197
Autologous Bone Marrow Stem Cells in Ischemic Stroke.
A Phase 1/2 study testing Infusion of autologous CD34+ stem cells into middle cerebral artery in people with Stroke, Acute and Infarction, Middle Cerebral Artery, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The aim of the study is to determine the safety and tolerability of an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome (TACS/PACS). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Acute, Infarction, Middle Cerebral Artery
- What is being tested?
- Infusion of autologous CD34+ stem cells into middle cerebral artery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms and signs of clinically definite acute stroke
- Time of stroke onset is known and treatment can be started within 7 days of onset
- CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
- The stroke is severe and conforming to the TACS phenotype (weakness, homonymous hemianopia and a focal cognitive deficit (e.g. aphasia) or reduction in consciousness) or PACS phenotype (two out of the three TACS criteria)
- An age range of 30-80 years old
- Stroke confined to MCA territory on CT or MRI brain imaging
- NIHSS score >/= 8
Who cannot join
- Known defect of clotting or platelet function (but patients on anti-platelet agents can enrol)
- Haematological causes of stroke
- Severe co-morbidity
- Hepatic or renal dysfunction
- The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
- Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is < 3.0 or > 20.0mmol/L
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- Patient is likely to be unavailable for follow-up e.g. no fixed home address
- Patients with evidence of life threatening infection (e.g. HIV) or life threatening illness (e.g. advanced cancer)
- Patient was already dependent in activities of daily living before the present acute stroke
- Patients who have been included in any other clinical trial within the previous month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Safety and Tolerability Study Following the Autologous Infusion of Immuno-selected CD34+ Subset Bone Marrow Stem Cells Into Patients With Acute Total Anterior Circulation Ischaemic Stroke
The aim of the study is to determine the safety and tolerability of an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome (TACS/PACS).
Read the detailed description
The proposed trial will involve the recruitment of a total of 10 patients.
The cells will be collected from each subject recruited, via bone marrow sampling. CD34+ stem cells will then be isolated and harvested during a process of immuno-selection in accordance with the principles of Good Manufacturing Practice. The CD34+ cells will then be directly infused into the area of the stroke intra-arterially using the middle cerebral artery.
Initially, the investigator will monitor each patient for a period of 6 months post-stem cell infusion. Thereafter, they will revert to their previous treatment regime in the clinic.
Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.
- Conditions
- Stroke, Acute, Infarction, Middle Cerebral Artery
- Being tested
- Infusion of autologous CD34+ stem cells into middle cerebral artery
- Keywords
- Stroke, Middle Cerebral Artery
- Medical subject headings
- Stroke, Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of autologous CD34+ stem cells into middle cerebral arteryBiological
intra-arterial infusion into ipsilateral MCA, via trans-femoral approach
| Study group | Role | What they receive |
|---|---|---|
| CD34+ stem/progenitor cell therapy | Experimental | Patients presenting within 7 days of onset with severe anterior circulation ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score≥8). CD34+ cells were collected from the bone marrow of the subjects before being delivered by catheter angiography into the ipsilesional middle cerebral artery. Receives: Biological: Infusion of autologous CD34+ stem cells into middle cerebral artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
Measured: Duration of study
Secondary outcomes (1)
Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nagy Habib, Professor, Principal investigator, Imperial College London U.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535197
- Sponsor's protocol ID
- HHSC/003
- Status last verified
- Jul 2019
- First submitted
- 25 Sep 2007
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banerjee S, Bentley P, Hamady M, Marley S, Davis J, Shlebak A, Nicholls J, Williamson DA, Jensen SL, Gordon M, Habib N, Chataway J. Intra-Arterial Immunoselected CD34+ Stem Cells for Acute Ischemic Stroke. Stem Cells Transl Med. 2014 Nov;3(11):1322-30. doi: 10.5966/sctm.2013-0178. Epub 2014 Aug 8.
PubMed 25107583Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.
PubMed 22163120
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Safety and Tolerability Study Following the Autologous Infusion of Immuno-selected CD34+ Subset Bone Marrow Stem Cells Into Patients With Acute Total Anterior Circulation Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT00535197
- Acronym / sponsor ID
- HHSC/003
- Conditions
- Stroke, Acute, Infarction, Middle Cerebral Artery
- Keywords
- Stroke, Middle Cerebral Artery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine the safety and tolerability of an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome (TACS/PACS).
Detailed description
The proposed trial will involve the recruitment of a total of 10 patients.
The cells will be collected from each subject recruited, via bone marrow sampling. CD34+ stem cells will then be isolated and harvested during a process of immuno-selection in accordance with the principles of Good Manufacturing Practice. The CD34+ cells will then be directly infused into the area of the stroke intra-arterially using the middle cerebral artery.
Initially, the investigator will monitor each patient for a period of 6 months post-stem cell infusion. Thereafter, they will revert to their previous treatment regime in the clinic.
Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD34+ stem/progenitor cell therapy | Experimental | Biological: Infusion of autologous CD34+ stem cells into middle cerebral arteryPatients presenting within 7 days of onset with severe anterior circulation ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score≥8). CD34+ cells were collected from the bone marrow of the subjects before being delivered by catheter angiography into the ipsilesional middle cerebral artery. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Symptoms and signs of clinically definite acute stroke
- Time of stroke onset is known and treatment can be started within 7 days of onset
- CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
- The stroke is severe and conforming to the TACS phenotype (weakness, homonymous hemianopia and a focal cognitive deficit (e.g. aphasia) or reduction in consciousness) or PACS phenotype (two out of the three TACS criteria)
- An age range of 30-80 years old
Key exclusion criteria (10 listed)
- Known defect of clotting or platelet function (but patients on anti-platelet agents can enrol)
- Haematological causes of stroke
- Severe co-morbidity
- Hepatic or renal dysfunction
- The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion of autologous CD34+ stem cells into middle cerebral arteryintra-arterial infusion into ipsilateral MCA, via trans-femoral approach | Biological | CD34+ stem/progenitor cell therapy |
Primary outcome
Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
Time frame: Duration of study
safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
1 secondary outcome
Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.
Time frame: Duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Results publication: PubMed 25107583Banerjee S, Bentley P, Hamady M, Marley S, Davis J, Shlebak A, Nicholls J, Williamson DA, Jensen SL, Gordon M, Habib N, Chataway J. Intra-Arterial Immunoselected CD34+ Stem Cells for Acute Ischemic Stroke. Stem Cells Transl Med. 2014 Nov;3(11):1322-30. doi: 10.5966/sctm.2013-0178. Epub 2014 Aug 8.
- Derived from this study: PubMed 22163120Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagy Habib, Professor principal investigator
Imperial College London U.K.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infusion of autologous CD34+ stem cells into middle cerebral artery in people with Stroke, Acute and Infarction, Middle Cerebral Artery, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results (time frame: Duration of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535197, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.